U.S. patent application number 15/931628 was filed with the patent office on 2020-09-03 for spinal implant system and methods of use.
This patent application is currently assigned to WARSAW ORTHOPEDIC INC.. The applicant listed for this patent is WARSAW ORTHOPEDIC INC.. Invention is credited to Mark C. Dace, John G. Heller, Chris E. Johnson, Nikhi S. Kulkarni, Craig M. Squires.
Application Number | 20200275955 15/931628 |
Document ID | / |
Family ID | 1000004827817 |
Filed Date | 2020-09-03 |
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United States Patent
Application |
20200275955 |
Kind Code |
A1 |
Squires; Craig M. ; et
al. |
September 3, 2020 |
SPINAL IMPLANT SYSTEM AND METHODS OF USE
Abstract
A spinal implant includes an intermediate portion and a first
portion extending in a transverse orientation from the intermediate
portion. The first portion includes an inner surface connectable
with vertebral tissue adjacent a lamina. A second portion is spaced
from the first portion and extends in a transverse orientation from
the intermediate portion. The second portion includes an inner
surface connectable with vertebral tissue adjacent a lamina. At
least one of the first portion and the second portion includes an
outer surface having a mating element engageable with a mating
element of a surgical instrument. Systems, surgical instruments and
methods are disclosed.
Inventors: |
Squires; Craig M.; (Cordova,
TN) ; Dace; Mark C.; (Collierville, TN) ;
Kulkarni; Nikhi S.; (Memphis, TN) ; Johnson; Chris
E.; (Germantown, TN) ; Heller; John G.;
(Atlanta, GA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
WARSAW ORTHOPEDIC INC. |
Warsaw |
IN |
US |
|
|
Assignee: |
WARSAW ORTHOPEDIC INC.
Warsaw
IN
|
Family ID: |
1000004827817 |
Appl. No.: |
15/931628 |
Filed: |
May 14, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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14957780 |
Dec 3, 2015 |
10695107 |
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15931628 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/7071 20130101;
A61B 17/7059 20130101 |
International
Class: |
A61B 17/70 20060101
A61B017/70 |
Claims
1-20. (canceled)
21. A spinal implant comprising: a body extending along an axis
between opposite first and seconds end, the body including a first
opening between the ends, the first opening extending through
opposite upper and lower surfaces of the body, the axis extending
at least partially between the upper and lower surfaces from the
first end to the second end; a first portion including a first end
surface that directly engages the first end and an opposite second
end surface, the first portion including a second opening between
the first and second end surfaces; a second portion including a
first end surface that directly engages the second end and an
opposite second end surface, the second portion including a third
opening between the first and second end surfaces of the second
portion, wherein at least one of the second end surfaces is
positioned above to the axis.
22. The spinal implant recited in claim 21, wherein each of the
second end surfaces is positioned above the axis.
23. The spinal implant recited in claim 21, wherein the axis is a
first axis and the second end surfaces define a second axis, the
second axis extending parallel to the first axis, the second axis
being spaced apart from the first axis.
24. The spinal implant recited in claim 21, wherein the axis is a
first axis and the second end surfaces define a second axis
positioned above the first axis, the second axis extending parallel
to the first axis.
25. The spinal implant recited in claim 21, wherein a distal
interface between the first end and the first end surface of the
first portion is positioned below the axis.
26. The spinal implant recited in claim 21, wherein a distal
interface between the first end and the first end surface of the
first portion is positioned below the axis and a distal interface
between the second end and the first end surface of the second
portion is positioned below the axis.
27. The spinal implant recited in claim 21, wherein the axis is a
first axis and a distal interface between the first end and the
first end surface of the first portion and a distal interface
between the second end and the first end surface of the second
portion define a second axis, the second axis extending parallel to
the first axis, the second axis being spaced apart from the first
axis.
28. The spinal implant recited in claim 21, wherein the axis is a
first axis and a distal interface between the first end and the
first end surface of the first portion and a distal interface
between the second end and the first end surface of the second
portion define a second axis, the second axis extending parallel to
the first axis, the second axis being positioned below the first
axis.
29. The spinal implant recited in claim 21, wherein: the first
portion includes an upper surface that is continuous with the upper
surface of the body, the upper surface of the first portion being
continuously curved from the first end surface of the first portion
to the second end surface of the first portion, the upper surface
of the first portion having a first radius of curvature; and the
second portion includes an upper surface that is continuous with
the upper surface of the body, the upper surface of the second
section being continuously curved from the first end surface of the
second portion to the second end surface of the second portion, the
upper surface of the second section having a second radius of
curvature equal to the first radius of curvature.
30. The spinal implant recited in claim 21, wherein: the first
portion includes a lower surface that is continuous with the lower
surface of the body, the lower surface of the first portion being
continuously curved from the first end surface of the first portion
to the second end surface of the first portion, the lower surface
of the first portion having a first radius of curvature; and the
second portion includes a lower surface that is continuous with the
lower surface of the body, the lower surface of the second section
being continuously curved from the first end surface of the second
portion to the second end surface of the second portion, the lower
surface of the second section having a second radius of curvature
equal to the first radius of curvature.
31. The spinal implant recited in claim 21, wherein the body is
continuously curved from the first end to the second end.
32. The spinal implant recited in claim 21, wherein: the lower
surface is continuously curved from the first end to the second
end, the lower surface having a first radius of curvature; and a
lower surface of the first portion is continuous with the lower
surface of the body, the lower surface of the first portion being
continuously curved from the first end surface of the first portion
to the second end surface of the first portion, the lower surface
of the first portion having a second radius of curvature that is
greater than the first radius of curvature.
33. The spinal implant recited in claim 21, wherein: the upper
surface is continuously curved from the first end to the second
end, the lower surface having a first radius of curvature; and an
upper surface of the first portion is continuous with the upper
surface of the body, the upper surface of the first portion being
continuously curved from the first end surface of the first portion
to the second end surface of the first portion, the upper surface
of the first portion having a second radius of curvature that is
greater than the first radius of curvature.
34. The spinal implant recited in claim 21, wherein the second
opening is positioned equidistant between the first and second end
surfaces of the first portion and the third opening is positioned
equidistant between the first and second end surfaces of the second
portion.
35. The spinal implant recited in claim 21, wherein an upper
interface between the first end and the first end surface of the
first portion is concavely curved and an opposite lower interface
between the first end and the first end surface of the first
portion is convexly curved.
36. The spinal implant recited in claim 21, wherein the first and
second portions each have a maximum height along the axis that is
greater than a maximum height of the body along the axis.
37. The spinal implant recited in claim 21, wherein the first and
second portions are monolithically formed with the body.
38. The spinal implant recited in claim 21, wherein the axis is a
first axis and the first and second portions each include an upper
surface that is continuous with the upper surface of the body, the
first portion including a first tooth extending outwardly from the
upper surface of the first portion, the second portion including a
second tooth extending outwardly from the upper surface of the
second portion, the teeth defining a second axis, the second axis
extending parallel to the first axis, the second axis being spaced
apart from the first axis.
39. A spinal implant comprising: an body extending along a
transverse axis between opposite anterior and posterior end, the
body including a first opening between the ends, the first opening
extending through opposite proximal and distal surfaces of the
body, the transverse axis extending at least partially between the
proximal and distal surfaces from the first end to the second end;
an anterior portion including a first end surface that directly
engages the first end and an opposite second end surface, the
anterior portion including a second opening between the first and
second end surfaces; and a posterior portion including a first end
surface that directly engages the second end and an opposite second
end surface, the posterior portion including a third opening
between the first and second end surfaces of the posterior portion,
wherein a first distal interface between the anterior portion and
the body and a second distal interface between the posterior
portion and the body are distal to the transverse axis, and the
second end surfaces is positioned proximal to the transverse
axis.
40. A spinal implant comprising: an body extending along a
transverse axis between opposite anterior and posterior end, the
body including a first opening between the ends, the first opening
being positioned equidistantly between the first and second ends,
the first opening extending through opposite proximal and distal
surfaces of the body, the transverse axis extending at least
partially between the proximal and distal surfaces from the first
end to the second end, the body being continuously curved along the
transverse axis from the first end to the second end; an anterior
portion including a first end surface that directly engages the
first end and an opposite second end surface, the anterior portion
including a second opening positioned equidistantly between the
first and second end surfaces, the anterior portion being
continuously curved along the transverse axis from the first end
surface to the second end surface; and a posterior portion
including a first end surface that directly engages the second end
and an opposite second end surface, the posterior portion including
a second opening positioned equidistantly between the first and
second end surfaces of the posterior portion, the posterior portion
being continuously curved along the transverse axis from the first
end surface of the posterior portion to the second end surface of
the posterior portion, wherein a first distal interface between the
anterior portion and the body and a second distal interface between
the posterior portion and the body are distal to the transverse
axis, and the second end surfaces is positioned proximal to the
transverse axis.
Description
TECHNICAL FIELD
[0001] The present disclosure generally relates to spinal implants
for the treatment of musculoskeletal disorders, and more
particularly to a spinal implant system that includes a spinal
implant and a method for treating a spine.
BACKGROUND
[0002] Spinal disorders such as degenerative disc disease, disc
herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis
and other curvature abnormalities, kyphosis, tumor, and fracture
may result from factors including trauma, disease and degenerative
conditions caused by injury and aging. Spinal disorders typically
result in symptoms including pain, nerve damage, and partial or
complete loss of mobility. For example, after a disc collapse,
severe pain and discomfort can occur due to the pressure exerted on
nerves and the spinal column.
[0003] Non-surgical treatments, such as medication, rehabilitation
and exercise can be effective, however, may fail to relieve the
symptoms associated with these disorders. Surgical treatment of
these spinal disorders includes fusion, fixation, discectomy,
laminectomy, laminoplasty and implantable prosthetics. For example,
laminoplasty treatments may employ implants, which may include
plates and bone fasteners to stabilize vertebrae and facilitate
healing. This disclosure describes an improvement over these prior
technologies.
SUMMARY
[0004] In one embodiment, a spinal implant is provided. The spinal
implant includes an intermediate portion and a first portion
extending in a transverse orientation from the intermediate
portion. The first portion includes an inner surface connectable
with vertebral tissue adjacent a lamina. A second portion is spaced
from the first portion and extends in a transverse orientation from
the intermediate portion. The second portion includes an inner
surface connectable with vertebral tissue adjacent a lamina. At
least one of the first portion and the second portion includes an
outer surface having a mating element engageable with a mating
element of a surgical instrument. In some embodiments, systems,
surgical instruments and methods are disclosed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] The present disclosure will become more readily apparent
from the specific description accompanied by the following
drawings, in which:
[0006] FIG. 1 is a perspective view of components of one embodiment
of a system in accordance with the principles of the present
disclosure;
[0007] FIG. 2 is a side view of the components shown in FIG. 1;
[0008] FIG. 3 is a perspective view of components of one embodiment
of a system in accordance with the principles of the present
disclosure;
[0009] FIG. 4 is a side view of the components shown in FIG. 3;
[0010] FIG. 5 is a perspective view of components of one embodiment
of a system in accordance with the principles of the present
disclosure;
[0011] FIG. 6 is a perspective view of components of one embodiment
of a system in accordance with the principles of the present
disclosure;
[0012] FIG. 7 is a break away perspective view of components of one
embodiment of a system in accordance with the principles of the
present disclosure;
[0013] FIG. 8 is a plan view of components of one embodiment of a
system in accordance with the principles of the present
disclosure;
[0014] FIG. 9 is a perspective view of components of one embodiment
of a system in accordance with the principles of the present
disclosure;
[0015] FIG. 10 is a perspective view of components of one
embodiment of a system in accordance with the principles of the
present disclosure;
[0016] FIG. 11 is a side view of the components shown in FIG.
10;
[0017] FIG. 12 is a perspective view of components of one
embodiment of a system in accordance with the principles of the
present disclosure disposed with vertebrae;
[0018] FIG. 13 is an axial view of components of one embodiment of
a system in accordance with the principles of the present
disclosure disposed with vertebrae;
[0019] FIG. 14 is a perspective view of components of one
embodiment of a system in accordance with the principles of the
present disclosure;
[0020] FIG. 15 is a perspective view of components of one
embodiment of a system in accordance with the principles of the
present disclosure disposed with vertebrae; and
[0021] FIG. 16 is an axial view of components of one embodiment of
a system in accordance with the principles of the present
disclosure disposed with vertebrae.
DETAILED DESCRIPTION
[0022] The exemplary embodiments of the spinal implant system and
related methods of use disclosed are discussed in terms of medical
devices for the treatment of musculoskeletal disorders and more
particularly, in terms of a spinal implant system that includes a
spinal implant and a method for treating a spine. In some
embodiments, the systems and methods of the present disclosure are
employed with a laminoplasty procedure. In some embodiments, the
present disclosure provides a spinal implant system employed with a
laminoplasty surgical technique that includes removing a portion of
vertebral tissue, such as, for example, a portion of a spinous
process and/or lamina and placing an implant adjacent and/or
between the tissue adjacent a vertebra to form a bridge. In some
embodiments, the spinal implant includes a plate. In some
embodiments, the spinal implant includes a gullwing shaped
plate.
[0023] In some embodiments, the spinal implant system comprises a
spinal implant that includes a laminoplasty plate. In some
embodiments, the spinal implant system comprises a spinal implant
that includes a french-door style laminoplasty implant. In some
embodiments, the spinal implant system is employed with a method
comprising a french door style laminoplasty. In some embodiments,
the spinal implant system is employed with a method comprising a
laminoplasty and includes a plate having material, such as, for
example, hydroxyapatite (HA) and/or a bone strut, disposed between
divided laminae to secure the laminae in an opened position.
[0024] In some embodiments, the spinal implant system comprises a
spinal implant that includes a plate having a curved cross-section
to be consistent with natural anatomy and central arms, which
provide stops for maintaining desired spacing between divided ends
of laminae. In some embodiments, the spinal implant includes a
plate having a roughened surface that mates against bone to provide
stability during insertion. In some embodiments, the spinal implant
includes a plate having a roughened surface for fixation to bone
once crimped and/or screwed into final position. In some
embodiments, the spinal implant includes a plate having additional
surface area for bony integration. In some embodiments, the spinal
implant includes a plate having teeth and/or rails located on bone
mating surfaces to provide fixation to bone once crimped and/or
screwed into final position. In some embodiments, the spinal
implant includes a plate having screw holes for attachment to bone.
In some embodiments, the spinal implant includes a plate having
screw holes oriented transverse to laminae and oriented such that a
screw may be placed along an axis of the laminae. In some
embodiments, the spinal implant includes a plate having a mating
element, such as, for example, a post, loop, ridge and/or hole for
alignment/attachment with a mating element of a surgical
instrument.
[0025] In some embodiments, the spinal implant system comprises a
spinal implant that includes a plate that connects to tissue
surrounding the laminae, such as, for example, lateral mass and/or
adjacent musculature. In some embodiments, the plate can be
manipulated and selectively fit to anatomy, such as, for example,
the plate can be made from titanium thin enough to be bent to match
the shape of a spinous process/laminae. In some embodiments, the
spinal implant system includes an insertion instrument that
includes a dovetail portion configured for mating with a dovetail
opening of a spinal implant. In some embodiments, the insertion
instrument includes an opening configured for disposal of a
surgical instrument, such as, for example, a drill, tap, and/or a
screw driver. In some embodiments, the spinal implant system
comprises one or more screws with a male driving feature and a
surgical instrument with a corresponding female feature for
holding, and driving the screws.
[0026] In some embodiments, the spinal implant system comprises a
spinal implant that includes a plate having a gripping element
disposed on an outside surface thereof that provides a gripping
capability for a surgical instrument to crimp the plate onto mating
bone. In some embodiments, this configuration provides for crimping
of the plate with bone by the surgical instrument to maintain a
firm, non-slip grip of the plate by the surgical instrument. In
some embodiments, this configuration provides increased protection
due to the close proximity to a spinal cord. In some embodiments,
the spinal implant system comprises screws employed with the plate
and including mating surfaces that mate with a mating surface in
screw holes of the plate, In some embodiments, the spinal implant
system comprises screws having an external feature that is designed
to mate with a corresponding internal feature on a screw driving
instrument. In some embodiments, this configuration prevents a head
of the screw from becoming deformed as a result of engagement with
the driver, which permits improved retention of the screw by the
driver. In some embodiments, this configuration reduces accidental
disengagement from the driver during a surgical procedure.
[0027] In some embodiments, the spinal implant system comprises one
or more trials. In some embodiments, the trials are dual-ended for
trialing a plurality of alternately configured and/or dimensioned
implants. In some embodiments, the trials include a handle that is
tapered to indicate whether an end is larger/smaller. In some
embodiments, the trials can be made from titanium and anodized for
color coding to provide visual indicia of a selected configuration
and/or dimension of an implant. For example, a green trial provides
visual indicia of a gullwing shaped plate.
[0028] In some embodiments, the spinal implant system is employed
with a french-door style cervical laminoplasty plate. In some
embodiments, the spinal implant system includes an instrument. In
some embodiments, the instrument includes one or more tips that can
be transversely oriented, curved or linear. In some embodiments,
the instrument includes one or more tips having mating elements,
such as, for example, teeth, for engaging, gripping and/or crimping
a spinal implant, as described herein.
[0029] In some embodiments, the spinal implant system includes an
implant having a curved section adjacent an intermediate portion
thereof and configured to be contoured with a patient's natural
anatomy, such as, for example, a spinal canal. In some embodiments,
the spinal implant system includes a spinal implant having a
roughened surface configured to mate with bone to provide stability
during insertion. In some embodiments, the spinal implant includes
additional surface area for bony integration. In some embodiments,
the spinal implant is provided that includes a screw hole
configured to receive a screw for attachment to bone.
[0030] In some embodiments, the spinal implant includes plate
material configured for manipulation such that the spinal implant
can be fit to a patient's anatomy. In some embodiments, the spinal
implant includes a material, such as, for example, a titanium sheet
that is bent to match a shape of a spinous process and/or a lamina.
In some embodiments, a spinal implant is provided that maintains
space between vertebral tissue where tissue is removed and is
configured to receive a graft or scaffold. In some embodiments, the
spinal implant includes a portion for receiving the graft or
scaffold to facilitate bone growth.
[0031] In some embodiments, the present disclosure may be employed
to treat spinal disorders such as, for example, degenerative disc
disease, disc herniation, osteoporosis, spondylolisthesis,
stenosis, tumor and fractures. In some embodiments, the present
disclosure may be employed with other osteal and bone related
applications, including those associated with diagnostics and
therapeutics. In some embodiments, the disclosed systems and
methods may be alternatively employed in a surgical treatment with
a patient in a prone or supine position, and/or employ various
surgical approaches to the spine, including posterior, posterior
mid-line, medial, lateral, postero-lateral approaches, and in other
body regions. The systems and methods of the present disclosure may
also be alternatively employed with procedures for treating the
lumbar, cervical, thoracic and pelvic regions of a spinal column.
The systems and methods of the present disclosure may also be used
on animals, bone models and other non-living substrates, such as,
for example, in training, testing and demonstration.
[0032] The present disclosure may be understood more readily by
reference to the following detailed description of the disclosure
taken in connection with the accompanying drawing figures, which
form a part of this disclosure. It is to be understood that this
disclosure is not limited to the specific devices, methods,
conditions or parameters described and/or shown herein, and that
the terminology used herein is for the purpose of describing
particular embodiments by way of example only and is not intended
to be limiting of the claimed disclosure. In some embodiments, as
used in the specification and including the appended claims, the
singular forms "a," "an," and "the" include the plural, and
reference to a particular numerical value includes at least that
particular value, unless the context clearly dictates otherwise.
Ranges may be expressed herein as from "about" or "approximately"
one particular value and/or to "about" or "approximately" another
particular value. When such a range is expressed, another
embodiment includes from the one particular value and/or to the
other particular value. Similarly, when values are expressed as
approximations, by use of the antecedent "about," it will be
understood that the particular value forms another embodiment. It
is also understood that all spatial references, such as, for
example, horizontal, vertical, top, upper, lower, bottom, outer,
inner, terminal (denoting position or location), left and right,
posterior, anterior, and the like, are for illustrative purposes
only and can be varied within the scope of the disclosure. For
example, the references "superior" and "inferior" are relative and
used only in the context to the other, and are not necessarily
"upper" and "lower".
[0033] As used in the specification and including the appended
claims, "treating" or "treatment" of a disease or condition refers
to performing a procedure that may include administering one or
more drugs to a patient in an effort to alleviate signs or symptoms
of the disease or condition. Alleviation can occur prior to signs
or symptoms of the disease or condition appearing, as well as after
their appearance. Thus, treating or treatment includes preventing
or prevention of disease or undesirable condition (for example,
preventing the disease from occurring in a patient, who may be
predisposed to the disease but has not yet been diagnosed as having
it). In addition, treating or treatment does not require complete
alleviation of signs or symptoms, does not require a cure, and
specifically includes procedures that have only a marginal effect
on the patient. Treatment can include inhibiting the disease, for
example, arresting its development, or relieving the disease, for
example, causing regression of the disease. For example, treatment
can include reducing acute or chronic inflammation; alleviating
pain and mitigating and inducing re-growth of new ligament, bone
and other tissues; as an adjunct in surgery; and/or any repair
procedure. As used in the specification and including the appended
claims, the term "tissue" includes soft tissue, ligaments, tendons,
cartilage and/or bone unless specifically referred to
otherwise.
[0034] The following discussion includes a description of a spinal
implant system and related methods of employing the spinal implant
system in accordance with the principles of the present disclosure.
Alternate embodiments are also disclosed. Reference is made in
detail to the exemplary embodiments of the present disclosure, some
of which are illustrated in the accompanying figures. Turning to
FIGS. 1-2, there are illustrated components of a spinal implant
system 10 including a spinal implant in accordance with the
principles of the present disclosure.
[0035] The components of spinal implant system 10 can be fabricated
from biologically acceptable materials suitable for medical
applications, including metals, synthetic polymers, ceramics and
bone material and/or their composites. For example, the components
of spinal implant system 10, individually or collectively, can be
fabricated from materials such as stainless steel alloys,
commercially pure titanium, titanium alloys, Grade 5 titanium,
super-elastic titanium alloys, cobalt-chrome alloys, superelastic
metallic alloys (e.g., Nitinol, super elasto-plastic metals, such
as GUM METAL.RTM.), ceramics and composites thereof such as calcium
phosphate (e.g., SKELITE.TM.), thermoplastics such as
polyaryletherketone (PAEK) including polyetheretherketone (PEEK),
polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK
composites, PEEK-BaSO.sub.4 polymeric rubbers, polyethylene
terephthalate (PET), fabric, silicone, polyurethane,
silicone-polyurethane copolymers, polymeric rubbers, polyolefin
rubbers, hydrogels, semi-rigid and rigid materials, elastomers,
rubbers, thermoplastic elastomers, thermoset elastomers,
elastomeric composites, rigid polymers including polyphenylene,
polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone
material including autograft, allograft, xenograft or transgenic
cortical and/or corticocancellous bone, and tissue growth or
differentiation factors, partially resorbable materials, such as,
for example, composites of metals and calcium-based ceramics,
composites of PEEK and calcium based ceramics, composites of PEEK
with resorbable polymers, totally resorbable materials, such as,
for example, calcium based ceramics such as calcium phosphate such
as HA, corraline HA, biphasic calcium phosphate, tricalcium
phosphate, or fluorapatite, tri-calcium phosphate (TCP), HA-TCP,
calcium sulfate, or other resorbable polymers such as polyaetide,
polyglycolide, polytyrosine carbonate, polycaroplaetohe and their
combinations, biocompatible ceramics, mineralized collagen,
bioactive glasses, porous metals, bone particles, bone fibers,
morselized bone chips, bone morphogenetic proteins (BMP), such as
BMR-2, BMP-4, BMP-7, rhBMP-2, or rhBMP-7, demineralized bone matrix
(DBM), transforming growth factors (TGF, e.g., TGF-.beta.),
osteoblast cells, growth and differentiation factor (GDF),
insulin-like growth factor 1, platelet-derived growth factor,
fibroblast growth factor, or any combination thereof.
[0036] Various components of spinal implant system 10 may have
material composites, including the above materials, to achieve
various desired characteristics such as strength, rigidity,
elasticity, compliance, biomechanical performance, durability and
radiolucency or imaging preference. The components of spinal
implant system 10, individually or collectively, may also be
fabricated from a heterogeneous material such as a combination of
two or more of the above-described materials.
[0037] Spinal implant system 10 can be employed, for example, in
laminoplasty procedures to treat patients suffering from a spinal
disorder to provide stabilization and decompression. The components
of spinal implant system 10 may be monolithically formed,
integrally connected or include fastening dements and/or
instruments, for example, as described herein.
[0038] Spinal implant system 10 includes a spinal implant 12
configured for disposal with vertebral tissue in a laminoplasty
procedure to treat patients suffering from a spinal disorder to
provide stabilization and decompression. In some embodiments,
spinal implant 12 is configured for stabilizing vertebral tissue,
such as, for example, divided and/or separated lamina, transverse
process, pars interarticularis, facet or spinous process portions
of one or more vertebral levels, as shown and described for example
with regard to FIGS. 15 and 16. In some embodiments, spinal implant
12 is configured for stabilizing one or more vertebral levels via
attachment with a vertebral level having removed, non-separated
portions of vertebral tissue, such as, for example, a lamina,
transverse process, pars interarticularis, facet or spinous
process, for example, such that a cavity is created in the
vertebral tissue, however, the tissue is not separated and spaced
apart, as shown and described for example with regard to FIG.
13.
[0039] Spinal implant 12 includes a plate 14 having a tissue
barrier 16. Tissue barrier 16 extends between an end 18 and an end
20, and includes a portion 22 disposed intermediate and/or
therebetween. Tissue barrier 16 includes a wall having a
substantially uniform, rectangular cross section. In some
embodiments, tissue barrier 16 can have alternate configurations,
such as, tubular, oval, oblong, irregular, undulating, non-uniform,
variable, hollow, wire, mesh and/or tapered.
[0040] End 18 is spaced apart from end 20, and portion 22 has a
non-planar face, such as, for example, an arcuate configuration
including a curvature that is oriented adjacent tissue, such as,
for example, a spinal canal. In some embodiments, portion 22 can
face and/or engage adjacent, opposing, and/or distributed locations
of vertebral tissue, as described herein, of a posterior, posterior
mid-line, medial, lateral and/or postero-lateral portion of
vertebrae. In some embodiments, portion 22 can comprise alternate
configurations, such as, for example, concave, linear or
angled.
[0041] End 18 includes a portion, such as, for example, a
transverse extension 28 that extends from portion 22 at an angular
orientation. In some embodiments, extension 28 includes an
undulating configuration, which comprises at least a portion of a
gullwing configuration of spinal implant 12, as shown in FIG. 1. In
some embodiments, the undulating configuration of extension 28
and/or the gullwing configuration of spinal implant 12 facilitates
manipulation thereof for engagement with anatomy, as described
herein.
[0042] Extension 28 includes a fixation surface, such as, for
example, surface 28a oriented to face and/or engage vertebral
tissue, such as, for example, a lamina. In some embodiments, all or
only a portion of extension 28 is engageable with a cut surface of
tissue, as described herein. In some embodiments, surface 28a is
roughened to facilitate engagement with tissue and provides an
initial provisional fixation with tissue. In some embodiments,
surface 28a includes teeth and/or rails to facilitate fixation with
tissue. In some embodiments, surface 28a is smooth, porous,
textured, rough, semi-porous, dimpled and/or polished.
[0043] In some embodiments, extension 28 can comprise a portion of
spinal implant 12 that abuts and/or engages a separated surface of
an anterior facing portion of vertebral tissue, as described
herein. In some embodiments, extension 28 can extend from portion
22 at various angular orientations, such as, for example, acute,
obtuse and in a range of 0-360 degrees. In some embodiments,
extension 28 can extend from portion 22 in a perpendicular,
transverse, substantially aligned, twisted or helical
orientation.
[0044] Extension 28 includes an inner surface 30 that defines a
cavity, such as, for example, an opening 32 configured to receive a
bone fastener, such as, for example, a bone screw 120, as discussed
herein and shown in FIGS. 5 and 6. Extension 28 includes an inner
surface 33 that defines a cavity, such as, for example, an opening
34 configured to receive a bone screw 120. Bone screw 120 attaches
extension 28 and spinal implant 12 with vertebral tissue, as
described herein. In some embodiments, extension 28 may include one
or a plurality of cavities configured for disposal of a bone
fastener.
[0045] In some embodiments, inner surface 33 defines an elongated
cavity, which includes openings 34a, 34b to selectively orient bone
screw 120 for penetrating vertebral tissue, as shown in FIGS. 3 and
4. In some embodiments, openings 34a, 34b communicate and are
overlapping to provide adjustability of bone screw 120 for
selectively orienting bone screw 120 for penetrating vertebral
tissue. In some embodiments, openings 34a, 34b are spaced and do
not overlap to provide adjustability of bone screw 120 for
selectively orienting bone screw 120 for penetrating vertebral
tissue. In some embodiments, the elongated cavity includes a
circular opening 34a that defines a center axis and a circular
opening 34b that defines a center axis. In some embodiments, the
elongated cavity can include one or a plurality of openings, which
may be disposed in linear alignment, series, an arc, undulating,
offset, staggered, uniform, non-uniform, angled, cluster, random
and/or cloverleaf configuration. In some embodiments, the center
axes are relatively disposed in a parallel or transverse
orientation. In some embodiments, openings 34a, 34b comprise a
figure eight configuration such that opening 34a communicates with
opening 34b to provide adjustability of bone screw 120 to
selectively orient bone screw 120 for penetrating vertebral tissue.
In some embodiments, an opening may have alternate configurations,
such as, for example, oval, oblong, triangular, square, hexagonal,
polygonal, irregular, uniform, non-uniform and/or tapered. In some
embodiments, opening 32 and/or opening 34 is configured to orient
bone screw 120 along a transverse axis of the lamina. In some
embodiments, opening 32 and/or opening 34 is configured to orient
bone screw 120 along a longitudinal axis of the lamina.
[0046] In some embodiments, spinal implant system 10 includes one
or more fasteners that may be engaged with vertebral tissue in
various orientations, such as, for example, series, parallel,
offset, staggered and/or alternate vertebral levels. In some
embodiments, the fasteners may comprise pedicle screws, mono-axial
screws, uni-planar screws, facet screws, fixed screws, tissue
penetrating screws, conventional screws, expanding screws, wedges,
anchors, buttons, clips, snaps, friction fittings, compressive
fittings, expanding rivets, staples, nails, adhesives, posts,
fixation plates and/or posts.
[0047] Extension 28 includes an outer surface 40, as shown in FIGS.
1 and 2. Outer surface 40 extends between an end 42 and an end 44.
Outer surface 40 includes a mating element, such as, for example, a
ridge 46. Ridge 46 is configured for engagement with a surgical
instrument, such as, for example, a surgical delivery instrument I,
as described herein. Ridge 46 includes a surface, such as, for
example, a ramp 48 and a surface, such as, for example, a ramp 50.
Ramps 48, 50 are oriented to define an apex 52. Ramp 48, ramp 50
and/or apex 52 are configured as a grip surface to resist and/or
prevent surgical delivery instrument I from disengagement and/or
slipping from spinal implant 12 to resist and/or prevent undesired
engagement and/or damage to adjacent tissue.
[0048] Ramps 48, 50 define end surfaces 54, 56. Surfaces 54, 56 are
configured to facilitate alignment and engagement of surgical
delivery instrument I with spinal implant 12, as described herein.
In some embodiments, ridge 46 extends in a transverse orientation
relative to ends 42, 44. In some embodiments, ridge 46 extends a
selected distance between ends 42, 44. In some embodiments, the
mating element includes a tooth disposed transversely along surface
40. In some embodiments, the mating element includes a plurality of
teeth. In some embodiments, one or more teeth may have various
configurations, for example, parallel, converging, diverging,
irregular, tapered, offset, staggered, uniform and non-uniform. In
some embodiments, the teeth may be disposed in a serial and/or
overlapping configuration to provide a matrix of teeth.
[0049] In some embodiments, extension 28 includes an end, such as,
for example, a flange 60 configured for plastic deformation to
conform to vertebral tissue. In some embodiments, flange 60 is
malleable and can be deformed, shaped and/or crimped to conform to
vertebral tissue prior to implantation or in situ. In some
embodiments, flange 60 can extend from extension 28 at various
angular orientations, such as, for example, acute, obtuse and in a
range of 0-360 degrees. In some embodiments, flange 60 can extend
from extension 28 in a perpendicular, transverse, substantially
aligned, twisted or helical orientation. In some embodiments, all
or a selected width and/or length of extension 28 is configured for
plastic deformation to conform to vertebral tissue, as described
herein.
[0050] End 20 includes a portion, such as, for example, a
transverse extension 70 that extends from portion 22 at an angular
orientation. In some embodiments, extension 70 includes an
undulating configuration, which comprises at least a portion of a
gullwing configuration of spinal implant 12. In some embodiments,
the undulating configuration of extension 70 and/or the gullwing
configuration of spinal implant 12 facilitate manipulation thereof
for engagement with anatomy, as described herein.
[0051] Extension 70 includes a fixation surface, such as, for
example, surface 70a oriented to face and/or engage vertebral
tissue, such as, for example, a lamina. In some embodiments, all or
only a portion of extension 70 is engageable with a cut surface of
tissue, as described herein. In some embodiments, surface 70a is
roughened to facilitate engagement with tissue and provides an
initial provisional fixation with tissue. In some embodiments,
surface 70a includes teeth and/or rails to facilitate fixation with
tissue, In some embodiments, surface 70a is smooth, porous,
textured, rough, semi-porous, dimpled and/or polished.
[0052] In some embodiments, extension 70 can comprise a portion of
spinal implant 12 that abuts and/or engages a separated surface of
an anterior facing portion of vertebral tissue, as described
herein. In some embodiments, extension 70 can extend from portion
22 at various angular orientations, such as, for example, acute,
obtuse and in a range of 0-360 degrees. In some embodiments,
extension 70 can extend from portion 22 in a perpendicular,
transverse, substantially aligned, twisted or helical
orientation.
[0053] Extension 70 includes an inner surface 72 that defines a
cavity, such as, for example, an opening 74 configured to receive a
bone screw 120. Extension 70 includes an inner surface 75 that
defines a cavity, such as, for example, an opening 76 configured to
receive a bone screw 120. Bone screw 120 attaches extension 70 and
spinal implant 12 with vertebral tissue, as described herein. In
some embodiments, extension 70 may include one or a plurality of
cavities configured for disposal of a bone fastener.
[0054] In some embodiments, inner surface 75 defines an elongated
cavity, which includes openings 76a, 76b to selectively orient bone
screw 120 for penetrating vertebral tissue, as shown in FIGS. 3 and
4. In some embodiments, openings 76a, 76b communicate and are
overlapping to provide adjustability of bone screw 120 for
selectively orienting bone screw 120 for penetrating vertebral
tissue. In some embodiments, openings 76a, 76b are spaced and do
not overlap to provide adjustability of bone screw 120 for
selectively orienting bone screw 120 for penetrating vertebral
tissue. In some embodiments, the elongated cavity includes a
circular opening 76a that defines a center axis and a circular
opening 76b that defines a center axis. In some embodiments, the
elongated cavity can include one or a plurality of openings, which
may be disposed in linear alignment, series, an arc, undulating,
offset, staggered, uniform, non-uniform, angled, cluster, random
and/or cloverleaf configuration. In some embodiments, the center
axes are relatively disposed in a parallel or transverse
orientation. In some embodiments, openings 76a, 76b comprise a
figure eight configuration such that opening 76a communicates with
opening 76b to provide adjustability of bone screw 120 to
selectively orient bone screw 120 for penetrating vertebral tissue.
In some embodiments, an opening may have alternate configurations,
such as, for example, oval, oblong, triangular, square, hexagonal,
polygonal, irregular, uniform, non-uniform and/or tapered. In some
embodiments, opening 74 and/or opening 76 is configured to orient
bone screw 120 along a transverse axis of the lamina. hi some
embodiments, opening 74 and/or opening 76 is configured to orient
bone screw 120 along a longitudinal axis of the lamina.
[0055] In some embodiments, intermediate portion 22 includes an
inner surface 77 that defines a cavity, such as, for example, an
opening 79. In some embodiments, opening 79 is configured to
provide an anchoring surface for spinal implant 12 with tissue. In
some embodiments, opening 79 provides an anchoring surface to
facilitate reconnecting of tissue, for example, to close an
incision adjacent a surgical site. In some embodiments, opening 79
is configured to provide an attachment surface for a surgical
delivery instrument, as described herein, to facilitate placement
of spinal implant 12. In some embodiments, opening 79 may have
alternate configurations, such as, for example, oval, oblong,
triangular, square, hexagonal, polygonal, irregular, uniform,
non-uniform and/or tapered. In some embodiments, intermediate
portion 22 includes an anchoring surface or an attachment surface,
as described above, for example, a detent, cavity, flange, clip,
hook, ring or mating element, which can be connected, attached
and/or manipulated by a practitioner and/or a surgical
instrument.
[0056] Extension 70 includes an outer surface 80, as shown in FIGS.
1 and 2. Outer surface 80 extends between an end 82 and an end 84.
Outer surface 80 includes a mating element, such as, for example, a
ridge 86. Ridge 86 is configured for engagement with surgical
delivery instrument I, as described herein. Ridge 86 includes a
surface, such as, for example, a ramp 88 and a surface, such as,
for example, a ramp 90. Ramps 88, 90 are oriented to define an apex
92. Ramp 88, ramp 90 and/or apex 92 are configured as a grip
surface to resist and/or prevent surgical delivery instrument I
from disengagement and/or slipping from spinal implant 12 to resist
and/or undesired engagement and/or damage to adjacent.
[0057] Ramps 88, 90 define end surfaces 96, 98. Surfaces 96, 98 are
configured to facilitate alignment and engagement of surgical
delivery instrument I with spinal implant 12, as described herein.
In some embodiments, ridge 86 extends in a transverse orientation
relative to ends 82, 84. In some embodiments, ridge 86 extends a
distance between ends 82, 84, hi some embodiments, the mating
element includes a tooth disposed transversely along surface 80. In
some embodiments, the mating element includes a plurality of teeth,
In some embodiments, one or more teeth may have various
configurations, for example, parallel, converging, diverging,
irregular, tapered, offset, staggered, uniform and non-uniform. In
some embodiments, the teeth may be disposed in a serial and/or
overlapping configuration to provide a matrix of teeth.
[0058] In some embodiments, extension 70 includes an end, such as,
for example, a flange 100 configured for plastic deformation to
conform to vertebral tissue. In some embodiments, flange 100 is
malleable and can be deformed, shaped and/or crimped to conform to
vertebral tissue prior to implantation or in situ. In some
embodiments, flange 100 can extend from extension 70 at various
angular orientations, such as, for example, acute, obtuse and in a
range of 0-360 degrees. In some embodiments, flange 100 can extend
from extension 70 in a perpendicular, transverse, substantially
aligned, twisted or helical orientation. In some embodiments, all
or a selected width and/or length of extension 70 is configured for
plastic deformation to conform to vertebral tissue, as described
herein.
[0059] In some embodiments, all or only a portion of plate 14 is
fabricated from a work hardenable material such that deformation of
flange 60 and/or flange 100 stiffens extensions 28, 70. In some
embodiments, extensions 28, 70 are monolithically formed with plate
14. In some embodiments, extensions 28, 70 are separate and
attachable with plate 14 in situ or prior to implantation. In some
embodiments, flanges 60, 100 are monolithically formed with
extensions 28, 70. In some embodiments, flanges 60, 100 are
separate and attachable to extensions 28, 70 in situ or prior to
implantation.
[0060] In some embodiments, spinal implant 12 includes a cavity
configured for disposal of bone growth promoting material. In some
embodiments, the bone growth promoting material can include bone
graft, allograft, xenograft, autograft, bone paste, bone chips,
Skelite.RTM., BMP and/or a titanium mesh material, such as, for
example, Trabeculite.TM. available from Tecomet, Wilmington, Mass.
In some embodiments, the cavity may include one or more agents, as
described herein. In some embodiments, extensions 28, 70 may have a
solid configuration, In some embodiments, extensions 28, 70 include
an outer surface having perforations that communicate with bone
growth promoting material disposed within the cavity.
[0061] Bone screw 120 includes a portion, such as, for example, a
head 122 and a portion, such as, for example a shaft 124, as shown
in FIG. 5. Head 122 includes a tool engaging portion, such as, for
example, a male mating portion 126. Male mating portion 126 is
configured for engagement with a surgical driver D, as shown in
FIG. 7. Male mating portion 126 includes a substantially square
configuration. Surgical driver D includes a female mating portion
128 configured for mating engagement with male mating portion 126.
Engagement of male mating portion 126 with female mating portion
128 resists and/or prevents disengagement from surgical driver D.
In some embodiments, surgical driver D includes a flange 130
configured to facilitate connection of surgical driver D with bone
screw 120. In some embodiments, flange 130 is resiliently biased
inwardly to capture male mating portion 126 with female mating
portion 128.
[0062] Shaft 124 includes an end 132 that forms a section, such as,
for example, a neck 134 with head 122. Neck 134 is disposed
adjacent head 122. Neck 134 is configured for disposal in a nested
configuration such that head 122 is disposed with a countersunk
portion of opening 32 and/or opening 34. Shaft 124 includes an
outer surface 136 having a thread 138. Thread 138 extends along a
length of shaft 124. In some embodiments, thread 138 is continuous
along surface 136. In some embodiments, thread 138 may include a
single thread turn or a plurality of discrete threads. In some
embodiments, other penetrating elements may be located on shaft
124, such as, for example, a nail configuration, barbs, expanding
elements, raised elements, ribs, and/or spikes to facilitate
engagement of shaft 124 with tissue. In some embodiments, thread
138 may be self-tapping or intermittent. In some embodiments, shaft
124 is configured having various widths to facilitate engagement
with tissue, such as, for example, bone screw 120, 120a, as shown
in FIGS. 5 and 6.
[0063] In some embodiments, bone screw 120 can includes a selected
diameter and or a selected length. In some embodiments, the
diameter is selected based on a width of a vertebral level to
maximize the diameter while maintaining the structural integrity of
bone screw 120 when engaged with tissue, as shown in FIG. 6. In
some embodiments, the length of bone screw 120 is determined based
on a patient anatomy, such as, for example, a length of a vertebral
level. In some cases, the length of a vertebral level may vary
between male and female patients.
[0064] Surgical delivery instrument I, as shown in FIG. 12, is
configured to facilitate manipulation, introduction, delivery
and/or positioning of spinal implant 12 with tissue. Surgical
delivery instrument I comprises a scissor and/or plier
configuration that includes an arm having a tip 150 and an arm
having a tip 152. Tips 150, 152 are connected via a pivot 162.
Pivot 162 is configured to facilitate rotation of tip 150 relative
to tip 152. Tips 150, 152 extend from the arms that are connected
to portions of a handle for operation.
[0065] Tip 150 includes a mating element, such as, for example, a
surface 154 that defines a cavity 156. Cavity 156 is configured for
disposal of ridge 46 and/or ridge 86. Tip 152 includes a mating
element, such as, for example, a surface 158 that defines a cavity
160. Cavity 160 is configured for disposal of ridge 46 and/or ridge
86.
[0066] Cavities 156, 160 align with ridges 46, 86 to facilitate
connection of surgical delivery instrument I with extension 28
and/or extension 70 such that ridges 46, 86 are disposed therein.
Surfaces 154, 158 engage ridges 46, 86 to grip plate 14 and resist
and/or prevent surgical delivery instrument I from disengagement
and/or slipping from plate 14 to resist and/or prevent undesired
engagement and/or damage to adjacent tissue. In some embodiments,
surfaces 154, 158 include protrusions, such as, for example, teeth
configured to facilitate gripping of spinal implant 12. In some
embodiments, tips 150, 152 include a transverse or curved
configuration. In some embodiments, tips 150, 152 include a
straight or linear configuration.
[0067] Surgical delivery instrument I engages extension 28 and/or
extension 70 to facilitate implantation of spinal implant 12.
Engagement of ridge 46 and/or ridge 86 with cavity 156 and/or
cavity 160 resists and/or prevents surgical delivery instrument I
from disengaging from spinal implant 12 to resist and/or prevent
undesired engagement and/or damage to tissue. In some embodiments,
tips 150, 152 are relatively rotated to capture spinal implant 12
therebetween to facilitate delivery to a surgical site. Compression
of tips 150, 152 applies a force to extension 28 and/or extension
70. Compression of tips 150, 152 causes extensions 28, 70 to deform
and/or crimp spinal implant 12 into a mating engagement with
tissue.
[0068] In operation, as shown in FIGS. 12 and 13, spinal implant
system 10, similar to the systems and methods described herein, is
employed with a surgical procedure, such as, for example, a
laminoplasty treatment of a spine of a patient including vertebrae
V. Spinal implant system 10 may also be employed with other
surgical procedures, such as, for example, discectomy, laminotomy,
laminectomy, nerve root retraction, foramenotomy, facetectomy,
decompression, and spinal, nucleus or disc replacement. For
example, vertebral levels V1, V2 and V3 of vertebrae V can be
removed, cut and/or weakened to open access and/or communication
with a spinal canal 13 and/or spinal canal tissue, to provide space
for a spinal cord. In some embodiments, spinal implant system 10
stabilizes vertebral levels V1, V2 and V3 for treatment and
healing.
[0069] In some embodiments, to treat the affected section of
vertebrae V, a medical practitioner obtains access to a surgical
site including posterior elements of vertebrae V in any appropriate
manner, such as through incision and retraction of tissues. Spinal
implant system 10, similar to the systems and methods described
herein, is employed with a surgical procedure, such as, for
example, a laminoplasty treatment of a spine of a patient including
vertebrae V. A cutting instrument (not shown) is employed to engage
a spinous process (not shown-removed) of vertebral level V1. The
spinous process is removed with the cutting instrument to form a
cavity, gap or space S between lamina L1 and lamina L2.
[0070] A relief C1 is cut down a medial cortical layer of lamina L1
to create a bone hinge H1. A relief C2 is cut down the medial
cortical layer of lamina L2 to create a bone hinge H2. In some
embodiments, reliefs C1, C2 can include a groove, gutter or trough,
and be formed using a high-speed burr drill. In some embodiments,
reliefs C1, C2 have a depth of approximately 3 to 4 millimeters and
a width of approximately 3 millimeters. In some embodiments, the
associated ligamentum flavum, capsule, and/or veins adjacent
vertebral level V1 can be separated to allow outward rotation of
the separated laminae L1, L2.
[0071] In some embodiments, trial implants, such as, for example,
trials 170, 170a, as shown in FIG. 7, are utilized to determine a
selected size and/or configuration of spinal implant 12. In some
embodiments, trials 170, 170a are configured with two ends each
that are configured with a different size, such as, for example, a
smaller end and a larger end. In some embodiments, trials 170, 170a
include a tapered handle configured to indicate the smaller end and
the larger end. In some embodiments, trials 170, 170a are
manufactured from titanium. In some embodiments, trials 170, 170a
are color coded to indicate dimension and configuration for
selecting a spinal implant. In some embodiments, one of trials 170,
170a is delivered and used to determine a selected size and/or
configuration of plate 14.
[0072] Surgical delivery instrument I is engaged with spinal
implant 12, as shown in FIG. 12, to facilitate delivery to a
surgical site. Surgical delivery instrument I is disposed adjacent
extension 28 and tips 150, 152 are relatively rotated about pivot
162. Cavity 156 is aligned with ridge 46 such that ridge 46 is
disposed in cavity 156 to facilitate connection of surgical
delivery instrument I with extension 28 to capture plate 14.
Surface 154 engages ridge 46 to grip plate 14 and resist and/or
prevent surgical delivery instrument I from disengagement and/or
slipping from plate 14 to resist and/or prevent undesired
engagement and/or damage to adjacent tissue. Tip 152 engages an
opposing portion of extension 28 such that tips 150, 152 apply a
compression force to extension 28 about tissue, as described
herein.
[0073] Similar to that described above, surgical delivery
instrument I is disposed adjacent extension 70 and tips 150, 152
are relatively rotated about pivot 162. Cavity 160 is aligned with
ridge 86 such that ridge 86 is disposed in cavity 160 to facilitate
connection of surgical delivery instrument I with extension 70 to
capture plate 14. Surface 158 engages ridge 86 to grip plate 14 and
resist and/or prevent surgical delivery instrument I from
disengagement and/or slipping from plate 14 to resist and/or
prevent undesired engagement and/or damage to adjacent tissue. Tip
150 engages an opposing portion of extension 70 such that tips 150,
152 apply a compression force to extension 70 about tissue, as
described herein.
[0074] Plate 14 is positioned with space S. Extensions 28, 70 are
disposed about lamina L1 and lamina L2, as described herein, for
engagement and/or fixation with vertebral tissue T1, T2.
Compression of tips 150, 152 applies a force to extension 28 and/or
extension 70 to deform and/or crimp plate 14 into engagement with
tissue, such as, for example, extension 28 is positioned with
tissue T1 of lamina L1 and extension 70 is positioned with tissue
T2 of lamina L2. Extension 28 is manipulated for deformation, as
described herein, about lamina L1 of vertebral level V1 for
engagement and/or fixation with tissue T1 of vertebral level V1.
Extension 70 is manipulated for deformation, as described herein,
about lamina L2 of vertebral level V1 for engagement and/or
fixation with tissue T2 of vertebral level V1.
[0075] In some embodiments, plate 14 is provided with bone growth
promoting material and/or an agent, as described herein, to provide
stabilization and decompression. Extensions 28, 70 are fastened
with vertebral level V1, as described herein. Surfaces 28a, 70a are
roughened and provide a provisional fixation of plate 14 to allow
for alignment of screws 120. A pilot hole or the like is formed in
tissue T1 and extension 28 is disposed such that opening 32 is
aligned with the pilot hole in tissue T1. Screw 120 is disposed
with opening 32 and inserted, drilled or otherwise fixed to tissue
T1 to attach extension 28 with lamina L1. A pilot hole or the like
is formed in tissue T2 and extension 70 is disposed such that
opening 74 is aligned with the pilot hole in tissue T2. Screw 120
is disposed with opening 74 and inserted, drilled or otherwise
fixed to tissue T2 to attach extension 70 with lamina L2.
[0076] A pilot hole or the like is formed in tissue T1 and
extension 28 is disposed such that opening 34 is aligned with the
pilot hole in tissue T1. Screw 120 is disposed with opening 34 and
inserted, drilled or otherwise fixed to tissue T1 to attach
extension 28 with lamina L1. A pilot hole or the like is formed in
tissue T2 and extension 70 is disposed such that opening 76 is
aligned with the pilot hole in tissue T2. Screw 120 is disposed
with opening 76 and inserted, drilled or otherwise fixed to tissue
T2 to attach extension 70 with lamina L2.
[0077] In some embodiments, as shown in FIG. 9, spinal implant
system 10 includes a surgical instrument, such as, for example, a
surgical drill guide 180 that is employed with a surgical
procedure, as described herein, to form one or more cavities, pilot
holes or the like in tissue. Drill guide 180 can be employed with
one or a plurality of surgical instruments including wires, awls,
taps, drills and/or drivers in connection with delivery,
orientation and/or fixation of plate 14 with tissue, as described
herein. Drill guide 180 includes a housing 182 having a surface 184
that defines a passageway 186. Passageway 186 is configured for
disposal of one or a plurality of the surgical instruments. Surface
184 and/or passageway 186 guide, align and/or direct the surgical
instruments to form one or more cavities, pilot holes or the like
in tissue at a surgical site. In some embodiments, housing 182 is
disposed within one or more of the openings of plate 14 to guide,
align and/or direct the surgical instruments to form one or more
cavities, pilot holes or the like in tissue at a surgical site. In
some embodiments, drill guide 180 is connected with plate 14 for
delivering plate 14 to a surgical site.
[0078] In some embodiments, housing 182 includes a uniform
cylindrical cross section configuration and a uniform dimension. In
some embodiments, housing 182 may have alternate cross section
configurations, such as, for example, oval, oblong, triangular,
rectangular, square and/or polygonal. In some embodiments, surface
184 has various surface configurations, such as, for example,
rough, threaded for connection with surgical instruments, arcuate,
undulating, porous, semi-porous, dimpled, polished and/or
textured.
[0079] Drill guide 180 includes a handle 188 that extends from
housing 182. Handle 188 includes indicia 190 that corresponds to a
selected size and/or configuration of one or more cavities, pilot
holes or the like to be formed in tissue at a surgical site, and/or
a spinal implant, such as, for example, a selected bone screw to be
disposed with the one or more cavities, pilot holes or the like.
For example, indicia 190 includes a numerical reference "3" to
indicate that housing 182 is configured and dimensioned to guide,
align and/or direct a surgical instrument that forms a 3 mm pilot
hole in tissue and/or corresponds to a 3 mm bone screw. In some
embodiments, one or more components of drill guide 180 are color
coded to indicate dimension and configuration of one or more
cavities, pilot holes or the like to be formed in tissue, and/or
spinal implants.
[0080] In some embodiments, as shown in FIGS. 10 and 11, spinal
implant system 10 includes a surgical drill guide 180a, similar to
drill guide 180, having an intermediate handle 188a and housings
182a, 182b, similar to housing 182, being disposed at opposing ends
of handle 188a. Housings 182a, 182b include indicia, similar to
indicia 190, which corresponds to a selected size and/or
configuration of one or more cavities, pilot holes or the like to
be formed in tissue at a surgical site, and/or a spinal implant,
such as, for example, a selected bone screw to be disposed with the
one or more cavities, pilot holes or the like. For example, handle
188a is tapered to a larger housing 182b and tapered to a smaller
housing 182a, to indicate a selected size and/or configuration of
one or more cavities, pilot holes or the like and/or a spinal
implant. In some embodiments, handle 188a includes indicia, for
example, a numerical reference "3" to indicate that housing 182a is
configured and dimensioned to guide, align and/or direct a surgical
instrument that forms a 3 mm pilot hole in tissue and/or
corresponds to a 3 mm bone screw. In some embodiments, handle 188a
includes indicia, for example, a numerical reference "5" to
indicate that housing 182b is configured and dimensioned to guide,
align and/or direct a surgical instrument that forms a 5 mm pilot
hole in tissue and/or corresponds to a 5 mm bone screw. In some
embodiments, housings 182a, 182b are color coded to indicate
dimension and configuration of one or more cavities, pilot holes or
the like to be formed in tissue, and/or spinal implants.
[0081] In some embodiments, screw 120 is disposed with portions
34a, 34b, as shown in FIG. 3, inserted and adjusted for selective
orientation with portions 34a, 34b for fixation with tissue T1 to
attach extension 28 with lamina L1. In some embodiments, screw 120
is disposed with portions 76a, 76b, as shown in FIG. 3, inserted
and adjusted for selective orientation with portions 76a, 76b for
fixation with tissue T2 to attach extension 70 with lamina L2.
[0082] One or more of the components of spinal implant system 10
can be made of radiolucent materials such as polymers. Radiomarkers
may be included for identification under x-ray, fluoroscopy, CT or
other imaging techniques. In some embodiments, the use of surgical
navigation, microsurgical and image guided technologies may be
employed to access, view and repair spinal deterioration or damage,
with the aid of spinal implant system 10. In some embodiments,
spinal implant system 10 may include one or a plurality of spinal
implants 12 for use with a single vertebral level or a plurality of
vertebral levels.
[0083] In some embodiments, spinal implant system 10 includes an
agent, which may be disposed, packed or layered within, on or about
the components and/or surfaces of spinal implant 12. In some
embodiments, the agent may include bone growth promoting material,
such as, for example, bone graft to enhance fixation of the
fixation elements with vertebrae. In some embodiments, the agent
may include one or a plurality of therapeutic agents and/or
pharmacological agents for release, including sustained release, to
treat, for example, pain, inflammation and degeneration. Upon
completion of the procedure, the non-implanted components,
instruments and assemblies are removed and the incision(s) are
closed.
[0084] In one embodiment, as shown in FIGS. 14-16, spinal implant
system 10, similar to the systems and methods described above with
regard to FIGS. 1-13, includes a spinal implant 212, similar to
spinal implant 12 described herein, which is employed with a
laminoplasty treatment configured for stabilizing one or more
vertebral levels via attachment with a vertebral level V1, which
has removed portions of vertebral tissue.
[0085] Spinal implant 212 includes a plate 214 having a tissue
barrier 216. Tissue barrier 216 extends between an end 218 and an
end 220, and includes a portion 222 disposed intermediate and/or
therebetween. Tissue barrier 216 includes a wall having a
substantially uniform, rectangular cross section. End 218 is spaced
apart from end 220, and portion 222 has a non-planar face, such as,
for example, an arcuate configuration including a curvature that is
oriented adjacent tissue, such as, for example, a spinal canal.
[0086] End 218 includes a portion, such as, for example, a
transverse extension 228 and a transverse extension 229. Extensions
228, 229 extend from portion 222 at an angular orientation.
Extensions 228, 229 include a fixation surface, such as, for
example, surfaces 228a, 229a that form a cavity oriented to face
and/or engage lamina. In some embodiments, extensions 228, 229 are
configured for plastic deformation to conform to vertebral tissue.
In some embodiments, extensions 228, 229 are malleable and can be
deformed, shaped and/or crimped to conform to vertebral tissue
prior to implantation or in situ.
[0087] Extension 228 includes an inner surface 230 that defines a
cavity, such as, for example, an opening 232 configured to receive
a bone fastener, such as, for example, a bone screw 120, as
discussed herein and shown in FIGS. 5 and 6. Bone screw 120
attaches extension 228 and spinal implant 212 with vertebral
tissue, as described herein. In some embodiments, extension 228 may
include one or a plurality of cavities configured for disposal of a
bone fastener. In some embodiments, extension 228 includes an inner
surface 231 having a countersunk portion that defines an angled
opening 234 to provide for transverse and/or angled orientation of
bone screw 120 to selectively orient bone screw 120 for penetrating
vertebral tissue.
[0088] Extension 228 includes an outer surface 240. Outer surface
240 extends between an end 242 and an end 244. Outer surface 240
includes a mating element, such as, for example, a ridge 246,
similar to ridge 46, described herein. Ridge 246 is configured for
engagement with surgical delivery instrument I, as described
herein.
[0089] End 220 includes a portion, such as, for example, a
transverse extension 270 and a transverse extension 271. Extensions
270, 271 extend from portion 222 at an angular orientation.
Extensions 270, 271 include a fixation surface, such as, for
example, surfaces 270a, 271a that form a cavity oriented to face
and/or engage lamina. In some embodiments, extensions 270, 271 are
configured for plastic deformation to conform to vertebral tissue.
In some embodiments, extensions 270, 271 are malleable and can be
deformed, shaped and/or crimped to conform to vertebral tissue
prior to implant or in situ.
[0090] Extension 270 includes an inner surface 272 that defines a
cavity, such as, for example, an opening 274 configured to receive
a bone screw 120, as described herein. Bone screw 120 attaches
extension 270 and spinal implant 212 with vertebral tissue, as
described herein. In some embodiments, extension 270 includes an
inner surface 269 having a countersunk portion that defines an
angled opening 276 to provide for transverse and/or angled
orientation of bone screw 120 to selectively orient bone screw 120
for penetrating vertebral tissue.
[0091] Extension 270 includes an outer surface 280. Outer surface
280 extends between an end 282 and an end 284. Outer surface 280
includes a mating element, such as, for example, a ridge 286,
similar to ridge 86 described herein.
[0092] In operation, as shown in FIGS. 15 and 16, spinal implant
system 10, similar to the systems and methods described herein, is
employed with a surgical procedure, such as, for example, a
laminoplasty treatment of a spine of a patient including vertebrae
V. A cutting instrument (not shown) is employed to engage a spinous
process (not shown-removed) of vertebral level V1. The spinous
process is removed with the cutting instrument to form a cavity,
gap or space S between lamina L1 and lamina L2.
[0093] A relief C1 is cut down a medial cortical layer of lamina L1
to create a bone hinge H1. A relief C2 is cut down the medial
cortical layer of lamina L2 to create a bone hinge H2. In some
embodiments, reliefs C1, C2 can include a groove, gutter or trough,
and be formed using a high-speed burr drill. In some embodiments,
reliefs C1, C2 have a depth of approximately 3 to 4 millimeters and
a width of approximately 3 millimeters. In some embodiments, the
associated ligamentum flavum, capsule, and/or veins adjacent
vertebral level V1 can be separated to allow outward rotation of
the separated laminae L1, L2.
[0094] Surgical delivery instrument I, as described herein, is
engaged with spinal implant 212, as shown in FIG. 15, to facilitate
delivery to a surgical site. Surgical delivery instrument I is
disposed adjacent extension 228 and tips 150, 152 are relatively
rotated about pivot 162. Cavity 156 is aligned with ridge 246 such
that ridge 246 is disposed in cavity 156 to facilitate connection
of surgical delivery instrument I with extension 228 to capture
plate 214. Surface 154 engages ridge 246 to grip plate 214 and
resist and/or prevent surgical delivery instrument I from
disengagement and/or slipping from plate 214 to resist and/or
prevent undesired engagement and/or damage to adjacent tissue. Tip
152 engages an opposing portion of extension 228 such that tips
150, 152 apply a compression force to extension 228 about tissue,
as described herein.
[0095] Similar to that described above, surgical delivery
instrument I is disposed adjacent extension 270 and tips 150, 152
are relatively rotated about pivot 162. Cavity 160 is aligned with
ridge 286 such that ridge 286 is disposed in cavity 160 to
facilitate connection of surgical delivery instrument I with
extension 270 to capture plate 214. Surface 158 engages ridge 286
to grip plate 214 and resist and/or prevent surgical delivery
instrument I from disengagement and/or slipping from plate 214 to
resist and/or prevent undesired engagement and/or damage to
adjacent tissue. Tip 150 engages an opposing portion of extension
270 such that tips 150, 152 apply a compression force to extension
270 about tissue, as described herein.
[0096] Extensions 228, 229 and extensions 270, 271 are positioned
with lamina L1 and lamina L2, respectively. Lamina L1 is rotated
outwardly about bone hinge H1 and lamina L2 is rotated outwardly
about bone hinge H2 to enlarge the cross-sectional area of spinal
canal T3. Plate 214 is positioned with space S between the
separated surfaces of tissue T1, T2. Extensions 228, 229 are
disposed with lamina L1 and extensions 270, 271 are disposed with
lamina L2 to provide stabilization and decompression.
[0097] As described above, extensions 228, 229 are manipulated to
deform about lamina L1 of vertebral level V1 for engagement and/or
fixation with tissue T1 of vertebral level V1. Extensions 270, 271
are manipulated to deform about lamina L2 of vertebral level Vi for
engagement and/or fixation with tissue T2 of vertebral level V1. In
some embodiments, extensions 228, 229, 270, 271 and plate 214 can
prevent the separated laminae from dosing from an implant position
toward an original, non-implant position. In some embodiments,
extensions 228, 229, 270, 271 tightly abut the spaced apart
laminae.
[0098] Surfaces 228a, 229a, 270a, 271a are roughened and provide a
provisional fixation of spinal implant 212 to allow for alignment
of screws 120. A pilot hole or the like is formed in tissue T1 and
extension 228 is disposed such that opening 232 is aligned with the
pilot hole in tissue T1. A screw 120 is disposed with opening 232
and inserted, drilled or otherwise fixed to tissue T1 to attach
extension 228 with lamina L1. A pilot hole or the like is formed in
tissue T2 and extension 270 is disposed such that opening 274 is
aligned with the pilot hole in tissue T2. A screw 120 is disposed
with opening 274 and inserted, drilled or otherwise fixed to tissue
T2 to attach extension 270 with lamina L2.
[0099] A transverse and/or angled pilot hole or the like is formed
in tissue T1 and extension 228 is disposed such that angled opening
234 is aligned with the pilot hole in tissue T1. A screw 120 is
disposed with opening 234 and inserted, drilled or otherwise fixed
to tissue T1 to attach extension 228 from a transverse orientation
with lamina L1. A transverse and/or angled pilot hole or the like
is formed in tissue T2 and extension 270 is disposed such that
angled opening 276 is aligned with the pilot hole in tissue T2. A
screw 120 is disposed with opening 276 and inserted, drilled or
otherwise fixed to tissue T2 to attach extension 270 from a
transverse orientation with lamina L2. Upon completion of the
procedure, the non-implanted components, instruments and assemblies
are removed and the incision(s) are closed.
[0100] It will be understood that various modifications may be made
to the embodiments disclosed herein. Therefore, the above
description should not be construed as limiting, but merely as
exemplification of the various embodiments. Those skilled in the
art will envision other modifications within the scope and spirit
of the claims appended hereto.
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